The Deeming Ban: What Should Vapers Be Doing Now?

The deeming regs and the predicate date

The “Cole Bill,” HR 2058, has picked up additional co-sponsors in the House of Representatives, including two Democrats. Reps. Collin Peterson of Minnesota and Brad Ashford of Nebraska have just signed on to the effort to change the predicate (or grandfather) date, which would allow existing products to remain on the market after the FDA’s two-year grace period set out in the deeming regulations.

The regulations take effect on August 8, but provide a two-year window for manufacturers to submit Premarket Tobacco Applications for their products. Almost no one believes that the FDA intends to act on a substantial number of applications. The cost for just one probably will exceed a million dollars, and each product sold must have a separate application to be considered for approval.

Further, there is no guarantee that the FDA will approve any application. It has already been proven that the FDA’s original plan was to ban e-liquid flavors, other than plain tobacco flavors, on August 8. The Office of Management and Budget forced that to be changed. However, once the deeming rule is in place, the FDA is free to make any additional rules they choose without review.

Changing the predicate date will not fix all the issues that the deeming regulations pose. The market will still be frozen as of August 8. However, it would provide businesses some certainty that the entire market will not collapse in two years, and thus encourage them to remain operating and continue the fight in Congress and the courts. Small businesses like vape shops would be hit especially hard as the 2018 ban approaches, since they would have to make tough decisions on renewing leases and buying inventory.

Confusion over which action to support? Support them all!

HR 2058 and the Cole-Bishop amendment

The Cole bill is one of two legislative efforts to derail the FDA’s attempt to wipe out the independent vapor products industry. The other is an amendment to the Agricultural Appropriations Bill, introduced by Reps. Tom Cole and Sanford Bishop. There has been considerable confusion over which of these vapers should support, which CASAA addressed in its latest newsletter.

HR 2058 continues to gain cosponsors and is part of a long-term effort to change the 2007 predicate date applied to new tobacco products by the Food, Drug, and Cosmetics Act. In fact, with the addition of Representative Collin Peterson (D-MN), HR 2058 is now considered a bipartisan bill. Moreover, although not specifically addressed by this legislation, urging support for this bill is important in our messaging efforts to change hearts and minds in Congress about the critical need to develop appropriate regulation for vapor products.

While it is unlikely that HR 2058 will advance successfully through the legislative process this year, it is wildly inaccurate and irresponsible to suggest that support for this bill is a “lost cause.” The simple truth is that support for this legislation will carry over to 2017 when the language (possibly with some additional language) is reintroduced and renumbered. CASAA also believes that it is unwise to put all of our resources behind one legislative strategy, especially when they are not mutually exclusive. Accordingly, CASAA will continue to offer support for not only HR 2058, but also for the Cole-Bishop Amendment to the Agricultural Appropriations Bill.

The federal lawsuit by the Right to be Smoke-Free Coalition

Additionally, Vaping360 encourages all vapers and vendors to support the Right to be Smoke-Free Coalition lawsuit against the FDA. Your donations go directly toward supporting the suit, which has just been combined by the DC District Court with the suit by Nicopure Labs.

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I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.

Jim, thank you for your articles about the fda. You are one of only a few people who seem to have actually researched this issue before writing the article, instead of copying facts from other articles. That’s why im hopeful that you can answer this question I’ve been worrying about: You stated, “However, once the deeming rule is in place, the FDA is free to make any additional rules they choose without review.” Does that mean that on August 8th 2016 the FDA can decide to ban flavors? Or scrap the 2 year window? Or anything they feel like? If not, what would stop them? If so, is there anything that would make this less likely than a certainty? Nobody seems to have picked up on this concern yet and I don’t understand why not.

Jim McDonald

Thanks, Caiti. Yes, they could ban flavors after August 8. Once e-cigs are officially “tobacco products,” they are pretty much free to do as they please. Their only concerns will be political (would a certain action create such an uproar that it might make the rest of their plan harder to implement?) and legal (might a certain action create grounds for more lawsuits?). Mitch Zeller has said many time since he took this job that the deeming regulations are “foundational” — that is, they just open the door to the larger regulatory work ahead.

I don’t think they could scrap the two-year window, since that’s written into the rule. But flavors, e-liquid ingredients, nic levels, power levels on mods…anything that wasn’t already spelled out in the rule can be added at any point after August 8. That’s why it’s so crucially important that we get the predicate date changed. I’m afraid a lot of vapers (and vendors!) don’t get what’s going to happen in the very near future if we don’t pressure Congress to fix that date.

Caiti Weiser

Thanks for your quick response. I’ve raised this concern to a few people including vape store employees, and I’ve been told I’m paranoid and I worry too much. Everyone I talk to seems to think we have two years to figure things out. People don’t realize 1. how short two years is, especially in politics, and 2. they may be personally affected much sooner than two years. I get the impression that people are procrastinating because of the “two year” thing. I will do what I can to disseminate this information because I believe we’d see vapers taking more action if they understood the implications. Maybe enough to make a difference (crossing fingers).

Jim McDonald

Agreed. Far too many people are being way too relaxed about this. Thanks for being involved!

theGOONIES

The way the law is written, only the products the tobacco companies and pharmaceutical companies offer will be legal. Since there will be no competition, tobacco companies will feel no need to improve their products and since smokers are somewhat a captive they hold power over us.

This whole law has nothing to do with our health but the tobacco and pharmaceutical companies competition.

Lame. And I will not comply

Jim McDonald

I mostly agree about tobacco companies having no need to improve their products. After all, they make more if you smoke. However, the way the rule is written, the tobacco company products will also have to go through the PMTA process — and I see no reason to believe that FDA will approve their applications.

theGOONIES

Their products are already approved as they are grandfathered in. They have no interest in making new or use able products ie. The products us vapers actually use ……mods tanks etc. They are more than happy restricting the product line to those crappie cigalikes that taste like crap are non refillable and contain all sorts of garbage. Most of the vape products that they sell, and the flavors are all covered before 2007 date thus matters little to them and they make hardly any money off them as soon few people actually enjoy them. Nasty little things those cigalikes.

Jim McDonald

Incorrect. There is no current product that was on the market in 2007. None of the Big T companies even made an e-cig till years later. Everything — everything — has to go through the PMTA process.